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NCT05291832 · ClinicalTrials.gov registry record · NA
Perioperative Audio for Anaesthesia
A NA study of Anesthesia, sponsored by Brain.fm.
- Completed
- Registry status
- NA
- Development phase
- 329
- Enrollment target
- 1
- Study location
NCT05291832: Completed NA study of Anesthesia, sponsored by Brain.fm.
NCT05291832 is a NA study of Anesthesia that has completed, run by Brain.fm. The registered enrollment target is 329 participants, below the 109,404-participant average among 57 other Anesthesia trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05291832, a NA study of Anesthesia, has completed, sponsored by Brain.fm.
- COMPLETED
- Registry status
- NA
- Development phase
- 329 participants
- Enrollment target
- 1
- Study location
Study Summary
Induction and emergence from propofol can be a difficult process for patients and healthcare workers, and long recovery times in particular can limit the rate of care. A double-blinded randomized controlled trial with 220 patients undergoing elective colonoscopy or endoscopy is proposed to test the impact of perioperative music on patient experience and recovery from propofol anaesthesia. Patients will be assigned at random to hear either rhythmic auditory stimulation (music designed to drive neural oscillations) or spectrally-matched noise (sound that produces the same levels of activity at the cochlea but not expected to drive neural entrainment). Bone-conduction headphones will be administered in pre-operation waiting and will play music (or matched noise) until propofol administration ceases, at which time the music (or noise) will be switched: Pre- and post-operational music is designed to be sedative and stimulative, respectively, created with methods that drive auditory entrainment to promote those states. Outcome measures will be recovery time and the patient's subjective experience (taken via survey).
Primary Outcome
The time spent in PACU (post-anaesthesia care unit) indicates how quickly patients recovered from propofol anaesthesia. Wakefulness (opening eyes) is noted with a button on the iPad. Audio is to be stopped if headphones are removed. Instead of formal discharge time, nurses are instructed to recover the equipment (iPad) during discharge and end the patient's session (with a button on the iPad). These times logged by the iPad should be coincident with discharge times.
Conditions Studied
Interventions
- OTHER Brain.fm Music
- OTHER Spectrally-matched Noise
Study Locations (1)
Texas
- Digestive Health Center of Plano - Plano
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 329 participants |
| Start Date | 2022-02-22 |
| Est. Completion | 2022-07-19 |
| Phase | NA |
What the finished NCT05291832 record still lists
NCT05291832 is an interventional study that assigns participants to a tested intervention. The registered 329 participants enrollment target is mid-sized for trials with a published cap, below the 109,404-participant average among 57 other Anesthesia trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Anesthesia appearing as the primary indexed condition, and to 2 interventions - of which Brain.fm Music is the first listed.
NCT05291832 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05291832 about?
NCT05291832 is a clinical study titled "Perioperative Audio for Anaesthesia". Induction and emergence from propofol can be a difficult process for patients and healthcare workers, and long recovery times in particular can limit the rate of care. A double-blinded randomized controlled trial with 220 patients undergoing elective colonoscopy or endoscopy is proposed to test the ...
What is the current status of trial NCT05291832?
This trial is currently completed. It is a NA study. The enrollment target is 329 participants. The study started on 2022-02-22. Estimated completion is 2022-07-19.
What conditions does trial NCT05291832 study?
This clinical trial studies the following conditions: Anesthesia.
What interventions are being tested in trial NCT05291832?
The interventions under investigation include: Brain.fm Music (OTHER), Spectrally-matched Noise (OTHER).
Who is sponsoring clinical trial NCT05291832?
This trial is sponsored by Brain.fm, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05291832 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05291832's enrollment target sits among peer trials
329 8th of 57 higher than 50 of 57 other Anesthesia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anesthesia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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